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Triadimefon Risk Assessments; Notice of Availability and Risk Reduction Options
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]
[Page 7945-7947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe06-55]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0258; FRL-7761-8]
Triadimefon Risk Assessments; Notice of Availability and Risk
Reduction Options
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's risk
assessments, and related documents for the triazole fungicide
triadimefon and for its free triazole metabolites, and opens a public
comment period on these documents. The triazole fungicides, which
include triadimefon, triadimenol, and propiconazole, and others, share
the common metabolites 1,2,4-triazole, triazole alanine, and triazole
acetic acid (also known as free triazoles). EPA has conducted an
aggregate risk assessment for the free triazole metabolites to ensure
that aggregate exposure and risk from these common metabolites meet the
current safety standards. The public is encouraged to suggest risk
management ideas or proposals to address the risks identified. EPA is
developing a Reregistration Eligibility Decision (RED) for triadimefon
through a modified, 4-Phase public participation process that the
Agency uses to involve the public in developing pesticide
reregistration and tolerance reassessment decisions. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.
DATES: Comments must be received on or before April 17, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0258; by one of the following methods:
? http://www.regulations.gov/. 
Follow the on-line
instructions for submitting comments.
? Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
? Hand Delivery: Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2005-0258. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is (703) 305-5805. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA --HQ-
OPP-2005-0258. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
on-line at http://www.regulations.gov/, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be captured
automatically and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or CD
ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm.
Docket: All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public
Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
[[Page 7946]]
holidays. The telephone number for the docket facility is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8195; fax
number: (703) 308-8041; e-mail address: pates.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information in a
disk or CD ROM that you mail to EPA, mark the outside of the disk or CD
ROM as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v.If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is releasing for public comment its human health and
environmental fate and effects risk assessments and related documents
for triadimefon, a triazole fungicide, and an aggregate risk assessment
for the free triazole metabolites, and encouraging the public to
suggest risk management ideas or proposals. Triadimefon is a systemic
fungicide used to control rust and mildew on apples, grapes, pears,
pineapple, and raspberries. Non-food uses include pine seedlings,
Christmas trees, residential and commercial turf, ornamentals, and
landscapes. EPA developed the risk assessments and risk
characterization for triadimefon through a modified version of its
public process for making pesticide reregistration eligibility and
tolerance reassessment decisions. Through these programs, EPA is
ensuring that pesticides meet current standards under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
Triadimefon is a triazole fungicide. It is used as a preharvest
foliar treatment on apples, pears, grapes, raspberries, Christmas
trees, and pine seedlings as well as a pre-/post-harvest treatment for
pineapple and a pre-plant soak/treatment for pine seeds. Triadimefon
products are marketed for homeowner use on residential lawns, landscape
ornamentals, trees, fruit trees, and grapes. Triadimefon-containing
products are also marketed for use by professional applicators on
residential turf, golf courses, other turf such as recreational/
commercial areas, and on ornamental plantings. In addition, other
triazole fungicides, which may metabolize to triazole conjugates, are
formulated into pharmaceutical products which are approved for use by
the Food and Drug Administration (FDA).
EPA is providing an opportunity, through this notice, for
interested parties to provide comments and input on the Agency's risk
assessments for triadimefon and for the free triazole metabolites
1,2,4-triazole, triazole alanine, and triazole acetic acid. Such
comments and input could address, for example, the availability of
additional data to further refine the risk assessments, such as the
need for a Developmental Neurotoxicity (DNT) study, information on
potential exposure to triazole conjugates from pharmaceutical products,
data on actual use patterns including rates, timing, and the kinds of
tasks that are required to produce agricultural commodities and other
products, as well as triadimefon-specific turf transferrable residue or
dislodgeable foliar residue data to help refine exposure and risk
estimates, or could address the Agency's risk assessment methodologies
and assumptions as applied to this specific pesticide.
Through this notice, EPA also is providing an opportunity for
interested parties to provide risk management proposals or otherwise
comment on risk management for triadimefon. Risks of concern associated
with the use of triadimefon include acute and chronic dietary risks,
ecological, residential and worker risks associated with the use on
turf, post-application risk to adults (mowing and gardening) and
youths/toddlers following application to turf, and worker risk due to
inhalation exposure for pine seed treatment. In targeting these risks
of concern, the Agency solicits information on effective and practical
risk reduction measures.
EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical, unusually high exposure to triadimefon or its free
triazole metabolites, compared to the general population.
EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and
[[Page 7947]]
Reregistration; Public Participation Process, published in the Federal
Register on May 14, 2004 (69 FR 26819) (FRL-7357-9), explains that in
conducting these programs, the Agency is tailoring its public
participation process to be commensurate with the level of risk, extent
of use, complexity of the issues, and degree of public concern
associated with each pesticide. For triadimefon, a modified, 4-Phase
process with one comment period and ample opportunity for public
consultation seems appropriate in view of its refined risk assessments
and other factors. However, if as a result of comments received during
this comment period EPA finds that additional issues warranting further
discussion are raised, the Agency may lengthen the process and include
a second comment period, as needed.. The decisions presented in the RED
may be supplemented by further risk mitigation measures when EPA
considers whether a cumulative assessment is necessary for the triazole
group of pesticides.
All comments should be submitted using the methods in ADDRESSES and
must be received by EPA on or before the closing date. Comments will
become part of the Agency Docket for Triadimefon. Comments received
after the close of the comment period will be marked ``late.'' EPA is
not required to consider these late comments.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory action.''
Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.
List of Subjects
Environmental protection, Triadimefon; Triazole Fungicides,
Pesticides and pests.
Dated: February 8, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-2151 Filed 2-14-06; 8:45 am]
BILLING CODE 6560-50-S